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FDA 510(k)

HEMAGEN CMV IGG KIT

K-Number: K944438 · 1997-02-20

ApplicantHemagen Diagnostics, Inc.
Decision Date1997-02-20
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HEMAGEN CMV IGG KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-02-20 under 510(k) number K944438. The device is classified under product code LFZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMAGEN CMV IGG KIT?

HEMAGEN CMV IGG KIT is a medical device that received FDA 510(k) clearance on 1997-02-20. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K944438.

When did HEMAGEN CMV IGG KIT receive FDA 510(k) clearance?

HEMAGEN CMV IGG KIT received FDA 510(k) clearance on 1997-02-20, under 510(k) number K944438.

Who is the listed applicant for HEMAGEN CMV IGG KIT?

The FDA 510(k) record lists Hemagen Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMAGEN CMV IGG KIT?

The FDA product code for HEMAGEN CMV IGG KIT is LFZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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